Mindfulness-Based Stress Reduction to Improve Well-being in Black Adult Cancer Survivors, Community Faith-based Mindfulness Ministry

Официальное название

Effectiveness of Mindfulness-Based Intervention on Patient Reported Outcomes of Black Adult Cancer Survivors: A Community Faith-Based Mindfulness Ministry (ComFaMM) Trial

Обзор

This clinical trial evaluates the impact of a Mindfulness-Based Stress Reduction (MBSR) program adjusted to include Christian principles on well-being in Black adult cancer survivors. Cancer survivors face a unique set of challenges that includes not only physical but also mental and spiritual well-being. Concerns related to both diagnosis and treatment profoundly impact the quality of life of Black cancer survivors. Mindfulness-based interventions (MBIs) have been shown to be effective in improving psychological resilience, reducing anxiety, and enhancing the quality of life among cancer survivors. However, there is little research focusing on these interventions among Black adult cancer survivors. Research has shown that interventions that include cultural experiences, such as the role of religion, spirituality and faith, are more effective in maintaining psychological well-being in Black men. A MBSR program adjusted to include Christian principles may improve the well-being in Black adult cancer survivors.

Подробное описание

PRIMARY OBJECTIVES:

I. Develop a culturally adapted Mindfulness-Based Stress Reduction (MBSR) intervention. (Phase 0) II. Pilot test the MBSR intervention to assess its feasibility, acceptability, and preliminary efficacy among a small group of participants. (Phase 0) III. To implement an overnight silent mindfulness retreat intervention that incorporates faith based cultural adaptations tailored for Black participants. (Phase I)

OUTLINE:

PHASE 0:

INTERVENTION DEVELOPMENT: Participants attend a focus group or a one-on-one interview over up to 60 minutes to gather insights of the cultural needs of Black adult cancer survivors.

PILOT TESTING: Patients participate in a group discussion with exercises and activities on study.

After completion of study intervention, patients are followed up at 3 months.

PHASE 1: Patients participate an overnight silent mindfulness retreat intervention, over 31 hours, with faith-based cultural adaptation emphasizing resilience and cultural relevant spiritual framing. The retreat includes sessions on different types of meditation, working with thoughts and emotions, stress, mindfulness techniques and how to integrate them, positive mind states, resiliency and resources, including educational handouts.

After completion of study intervention, patients are followed up at 3 and 6 months.

Вмешательства

• Другое Educational Intervention
  Receive education resource handouts
• Другое Discussion
  Attend a focus group
• Поведенческое Mindfulness Relaxation
  Complete silent mindfulness retreat intervention
• Другое Interview
  Attend a one-on-one interview
• Другое Questionnaire Administration
  Complete study-related questionnaires

Первичные конечные точки

• Spiritual well-being [Срок оценки: Pre-MBI, Post-MBI (immediately after MBI), 3 months, 6months]

Вторичные конечные точки (4)

• Quality of life (QOL) (Phase 1) [Срок оценки: Pre-MBI, Post-MBI, 3 months, 6months]
• Level of resilience - CD-RISC (Phase 1) [Срок оценки: Pre-MBI, Post-MBI, 3 months, 6months]
• Level of resilience - RSA [Срок оценки: Pre-MBI, Post-MBI, 3 months, 6months]
• Overall assessment of the MBI and perception of MBI value (Phase 1) [Срок оценки: Post-MBI, 3 months, 6months]

Критерии участия

Критерии включения

• PHASE 0 DEVELOPMENT: Adults aged 18 or older
• PHASE 0 DEVELOPMENT: Ability to speak, read and understand English
• PHASE 0 DEVELOPMENT: Individuals personally affected by cancer, either through their own diagnosis or that of a loved one
• PHASE 0 DEVELOPMENT: Self-identifies as Black or African American
• PHASE 0 DEVELOPMENT: Membership or affiliation with a faith-based organization
• PHASE 0 PILOT TESTING: Adults aged 18 or older
• PHASE 0 PILOT TESTING: History of a cancer diagnosis
• PHASE 0 PILOT TESTING: Meets National Cancer Institute (NCI) cancer survivor definition (a person is a survivor from the time of diagnosis until the end of life)
• PHASE 0 PILOT TESTING: Ability to physically attend live MBI and complete web-based surveys and assessments
• PHASE 0 PILOT TESTING: Ability to speak, read and understand English
• PHASE 1: Adults aged 18 or older
• PHASE 1: History of a cancer diagnosis
• PHASE 1: Meets NCI cancer survivor definition (a person is a survivor from the time of diagnosis until the end of life)
• PHASE 1: Ability to physically attend live MBI and complete web-based surveys and assessments
• PHASE 1: Ability to speak, read and understand English
• PHASE 2: Adults aged 18 or older
• PHASE 2: History of a cancer diagnosis
• PHASE 2: Meets NCI Cancer Survivor definition (a person is a survivor from the time of diagnosis until the end of life)
• PHASE 2: Ability to physically attend live MBI and complete web-based surveys and assessments
• PHASE 2: Ability to speak, read and understand English

Критерии исключения

• PHASE 0 DEVELOPMENT: Does not meet the inclusion criteria
• PHASE 0 DEVELOPMENT: Unable or unwilling to participate in the recorded sessions
• PHASE 0 PILOT TESTING: Inability to attend and participate in MBI due to medical or psychological hardship
• PHASE 0 PILOT TESTING: Inability to speak, read and understand English
• PHASE 1: Inability to attend and participate in MBI due to medical or psychological hardship
• PHASE 1: Inability to speak, read and understand English
• PHASE 1: Participated in phase 0 of the study
• PHASE 2: Inability to attend and participate in MBI due to medical or psychological hardship
• PHASE 2: Inability to speak, read and understand English
• PHASE 2: Participated in phase 0 or phase 1 of the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Mayo Clinic in Florida — Jacksonville

Идентификаторы

NCT: NCT06767475 · MC240901 · 24-006322

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗